ISO 9001:2015 Clause 7.5

What is ISO 9001:2015 Clause 7.5?

Clause 7.5 of ISO 9001:2015 focuses on the control of documented information within the quality management system. It outlines requirements for creating, updating, controlling, and making available documented information necessary for the effectiveness of the quality management system.

Key points outlined in Clause 7.5 include:

This clause emphasizes the need for organizations to manage various types of documents, including manuals, procedures, policies, and records. It specifies requirements for controlling document distribution, ensuring that relevant versions of documents are available at points of use, preventing the unintended use of obsolete documents, and identifying changes and the current revision status of documents.

Overall, Clause 7.5 helps organizations maintain the integrity and accuracy of their documented information to support the consistent operation and continual improvement of their quality management system.

How do you comply with Clause 7.5?

Compliance with Clause 7.5 of ISO 9001:2015 involves several steps to effectively control documented information within your organization’s quality management system:

Document Identification and Control:

Identify all relevant documents, including manuals, procedures, work instructions, forms, records, etc., needed for your quality management system.

Document Creation and Approval:

Establish a process for creating new documents or revising existing ones. Ensure that these documents go through an approval process before being used.

Documented Information Accessibility:

Make sure that the current versions of documents are available at their points of use. This can involve physical or digital access, ensuring that employees can readily access the necessary documents.

Document Review and Revision:

Implement procedures for regular document reviews and updates. This includes identifying when documents need revision, tracking changes, and ensuring proper approval before implementing revisions.

Document Distribution:

Control the distribution of documents to ensure that the correct and current versions are in use. This might involve version control, ensuring that obsolete versions are removed or marked as such.

Obsolete Document Management:

Establish procedures for managing obsolete documents. Ensure they are either archived or removed from use to prevent accidental use.

Document Retention:

Define the duration for which certain documents need to be retained or archived, especially records that are essential for compliance or historical purposes.

Training and Awareness:

Ensure that employees are trained in the use of documented information relevant to their roles. This involves educating them about where to find documents, how to use them, and how to identify current versions.

Technology and Systems:

Implement appropriate document management systems or technology tools that facilitate version control, access, and tracking of document changes.

Monitoring and Review:

Regularly monitor and review your document control processes to ensure they remain effective. This includes conducting internal audits to check compliance and identifying areas for improvement.

By following these steps and integrating them into your organization’s processes, you can effectively comply with Clause 7.5 of ISO 9001:2015, ensuring proper control and management of documented information within your quality management system.

Other ISO 9001:2015 Clauses:

• The Complete Clause 7
• Clause 7.1.1
• Clause 7.1.2
• Clause 7.1.3
• Clause 7.1.4
• Clause 7.1.5
• Clause 7.1.6
• Clause 7.2
• Clause 7.3
• Clause 7.4
• Clause 7.5.1
• Clause 7.5.2
• Clause 7.5.3

What is the History of Clause 7.5?

Clause 7.5, which focuses on the control of documented information, has its roots in the evolution of ISO 9001 and quality management systems.

Previous Versions

In previous versions of ISO 9001 (such as ISO 9001:2008), the requirements related to documentation were more extensive and detailed. There were separate clauses for documents and records, with specific requirements for quality manuals, documented procedures, and quality records.

ISO 9001:2015

However, with the release of ISO 9001:2015, the structure and approach underwent significant changes. The revision aimed to make the standard more adaptable to various organizations and industries while emphasizing essential principles and reducing prescriptive documentation requirements.

Clause 7.5 in ISO 9001:2015 merged the previous requirements for documents and records into a more unified approach known as “documented information.” This shift in language aimed to encompass various forms of information, including traditional documents, electronic files, databases, and more.

The change in terminology from “document” and “record” to “documented information” was deliberate, allowing organizations to adopt a broader perspective on how they control and manage information within their quality management systems. This change encouraged a more flexible approach, enabling organizations to determine the most suitable methods for creating, updating, controlling, and making information available while emphasizing the importance of maintaining accuracy and relevance.

The evolution of Clause 7.5 reflects a shift toward a more flexible and adaptable quality management system, allowing organizations to focus on the effectiveness and efficiency of their processes without being overly burdened by rigid documentation requirements.

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